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New Drugs, Devices, Indications, and Approvals

  • Alglucosidase alfa (Lumizyme) has been approved by the FDA for the treatment of patients older than 8 with late (noninfantile) onset Pompe disease (GAA deficiency) who do not have evidence of cardiac hypertrophy.1
  • Dutasteride and tamsulosin (Jalyn) has been approved by the FDA in a fixed-dose combination product for treating symptomatic benign prostatic hypertrophy.2
  • Gatifloxacin ophthalmic solution 0.5% (Zymaxid) has been approved by the FDA to treat bacterial conjunctivitis caused by susceptible bacterial strains.3 It has the highest concentration of gatifloxacin ophthalmic on the U.S. market.
  • Memantine hydrochloride (Namenda XR) has been approved by the FDA as an extended-release product to treat moderate to severe dementia of the Alzheimer's type.4 It is available as a 28 mg, once-daily dosage form. The immediate-release product is dosed twice daily.
  • Mesenchymal stem cells for intravenous infusion (MSCs, Prochymal) formulated into Prochymal has been granted orphan drug status to treat Type 1 diabetes mellitus (T1DM).5 This agent is in Phase 2 clinical trials in a collaboration with the Juvenile Diabetes Research Foundation as a treatment for patients with newly diagnosed T1DM.
  • Mometasone furoate/formoterol fumarate (Dulera) has been approved by the FDA as a combination treatment for asthmatics aged 12 and older.6
  • Naproxen/esomeprazole (Vimovo) has been approved by the FDA as a fixed combination for patients with arthritis who are at risk for developing gastric ulcers.7
  • Pioglitazone/metformin (ACTOplus met XR) has been approved by the FDA in an extended-release fixed combination for treating Type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.8
  • Ranibizumab (Lucentis) has received a new indication from the FDA for treating retinal vein occlusion.9 The original approval of ranibizumab was for wet age-related macular degeneration.
  • Tramadol HCl, orally disintegrating tablets (Rybix ODT), have been approved by the FDA for treating moderate to moderately severe pain in patients 16 years of age and older.10

Pipeline

  • Dronedarone (Multaq) is being investigated as to whether it can reduce major cardiovascular events in patients being treated with the agent for atrial fibrillation.11 Study endpoints will include a reduction in a major cardiovascular event such as stroke or myocardial infarction, or a reduction in cardiovascular hospitalization or death.
  • The combination product ibuprofen and famotidine (to be known as Duexa) has been filed as a new drug application (NDA) for reducing the risk of developing upper gastrointestinal (GI) ulcers in patients with pain and arthritis.12 Two Phase 3 trials showed about a 50% reduction in GI ulcers in combination treatment compared with ibuprofen alone.
  • Rifaximin (Xifaxan) has been submitted to the FDA at its higher dose (550 mg) for treatment of nonconstipation irritable bowel syndrome (Non-C-IBS) and IBS-related bloating.13 Rifaximin already has approval from the FDA for hepatic encephalopathy and diarrhea.
  • TC-5214 has begun Phase 3 clinical trials.14 It is a nicotinic channel blocker for the adjunctive treatment of major depressive disorder in adults who have had an inadequate response to selective serotonin reuptake inhibitors (SSRIs) or serotonin/norepinephrine reuptake inhibitors (SNRIs). A Phase 2 study evaluating TC-5214 as a second-line (“switch”) monotherapy is planned for this year.
  • An NDA for vilazodone has been filed for treating major depressive disorder.15 It is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist.

Safety, Warnings, and Label Changes

  • Tramadol and tramadol/acetaminophen have undergone a label change related to strengthened warnings of the risk of suicide for patients who are addiction-prone, taking tranquilizers, drinking alcohol, or taking other central-nervous-system-active drugs.16 Addictive effects might occur when tramadol is combined with alcohol, other opioids, or illicit drugs that have central-nervous-system-depressive effects. Serious potential consequences of overdosage are CNS and/or respiratory depression, and death.
  • Earlier this year, the FDA once again updated the warning related to severe liver injury related to the use of propylthiouracil (PTU).17 This time, PTU has garnered a boxed warning, which includes reports of severe hepatotoxicity and acute liver failure in both adults and children. Some of these reactions were fatal. Use of PTU should be reserved for patients who do not tolerate other treatments for hyperthyroidism, such as methimazole, radioactive iodine, or are not surgery candidates. PTU might be preferred over methimazole just before and/or during the first trimester of pregnancy due to the occurrence of birth defects with methimazole during this timeframe. A medication guide has been developed and is to be given to patients when they fill PTU prescriptions. The guide alerts patients to the signs and symptoms of hepatotoxicity. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

  1. Genzyme receives FDA approval for lumizyme for Pompe disease. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100525006514. Accessed June 30, 2010.
  2. Dennis M. FDA approves GlaxoSmithKline’s combination BPH drug Jalyn. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=B5F703CADB0347DF970A7B7542D99982&logRowId=369156. Accessed June 30, 2010.
  3. Allergan receives FDA approval for Zymaxid ophthalmic solution. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/189397.php. Accessed June 29, 2010.
  4. Forest and Merz announce FDA approval of Namenda XR for the treatment of moderate to severe dementia of the Alzheimer’s type. Forest Laboratories website. Available at: http://www.frx.com/news/PressRelease.aspx?ID=1440385. Accessed June 30, 2010.
  5. Osiris Therapeutics receives FDA orphan drug designation for stem cell treatment for Type 1 diabetes. Osiris Therapeutics website. Available at: http://osiris.com/pdf/2010-05-04%20T1D%20Orphan%20Drug%20Designation.pdf. Accessed June 30, 2010.
  6. FDA approves Merck’s new lung drug Dulera. The Economic Times website. Available at: http://economictimes.indiatimes.com/articleshow/6087079.cms. Accessed June 30, 2010.
  7. Dane L. FDA approves AstraZeneca, Pozen’s Vimovo. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=0C2915EE4D2D47D287D41D90DFE4240D. Accessed June 30, 2010.
  8. ACTOplus met XR available for diabetes. Monthly Prescribing Reference website. Available at: http://www.empr.com/actoplus-met-xr-available-for-diabetes/article/172985/. Accessed June 30, 2010.
  9. Dennis M. Roche’s Lucentis garners expanded FDA approval for macular oedema. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=5146664F5A4C48108209D15EA744A614&logRowId=370643. Accessed June 30, 2010.
  10. Rybix ODT launched for moderate to moderately severe pain. Monthly Prescribing Reference website. Available at: http://www.empr.com/rybix-odt-launched-for-moderate-to-moderately-severe-pain/article/172743/. Accessed June 30, 3010.
  11. Dennis M. Sanofi-Aventis begins late-stage study of Multaq in patients with permanent AF. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E43104A2DB604649A812E69C58F89304&logRowId=364228. Accessed July 7, 2010.
  12. FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients. Monthly Prescribing Reference website. Available at: http://www.empr.com/fda-accepts-nda-for-duexa-for-ulcer-risk-reduction-in-arthritis-patients/article/171054/. Accessed July 7, 2010.
  13. Salix Pharmaceuticals announces NDA submission for Xifaxan550 for treatment of non-constipation irritable bowel syndrome. Salix Pharmaceuticals website. Available at: http://salix.com/news/stories/20100608.aspx. Accessed June 9, 2010.
  14. AstraZeneca and Targacept initiate Phase 3 clinical development of TC-5214 as an adjunct treatment for major depressive disorder. Targacept website. Available at: http://www.targacept.com/wt/page/pr_1277240993. Accessed June 29, 2010.
  15. Clinical Data, Inc. announces FDA acceptance of new drug application for Vilazodone for the treatment of major depressive disorder. Clinical Data Inc. website. Available at: http://clda.com/uploads/CLDA%20NDA%20acceptance%20FINAL.pdf. Accessed July 7, 2010.
  16. Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label change. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm. Accessed July 8, 2010.
  17. FDA Drug Safety Communication: New boxed warning on severe liver injury with propylthiouracil. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209023.htm. Accessed July 8, 2010.

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